Clinical Trial: Single Dose Pharmacokinetic (PK) Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome
Brief Summary:
The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome (FXS) or Angelman syndrome (AS).
- The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101 following a single 5 mg dose of OV101 in adolescents with FXS or AS.
- Secondary objectives are to determine the safety and tolerability of a single 5 mg dose of OV101 in adolescents with FXS or AS.
Detailed Summary:
Sponsor: Ovid Therapeutics Inc.
Current Primary Outcome:
- Measurement of maximum plasma concentration achieved following a single dose of OV101 [ Time Frame: 10 hours ]Maximum plasma concentration (Cmax)
- Measurement of time of maximum plasma concentration following a single dose of OV101 [ Time Frame: 10 hours ]Time after administration of drug when maximum plasma concentration is reached (Tmax)
- Measurement of plasma half-life following a single dose of OV101 [ Time Frame: 10 hours ]Plasma half-life (T1/2)
- Measurement of the area under the plasma concentration versus time curve following a single dose of OV101 [ Time Frame: 10 hours ]Area under the curve from 0 to 10 hours (AUC 0-10)
- Measurement of clearance following a single dose of OV101 [ Time Frame: 10 hours ]Total body clearance (CL)
- Measurement of the apparent volume of distribution following a single dose of OV101 [ Time Frame: 10 hours ]Apparent volume of distribution during terminal phase (Vz)
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram (ECG) [ Time Frame: 10 hours ]
Original Secondary Outcome: Same as current
Information By: Ovid Therapeutics Inc.
Dates:
Date Received: April 6, 2017
Date Started: April 3, 2017
Date Completion: December 2017
Last Updated: April 10, 2017
Last Verified: April 2017